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Blue Smoke
Aurora
All PlasmoClean systems are independently tested and certified under international medical and safety standards to ensure full regulatory compliance and proven reliability.
All PlasmoClean systems are independently tested and certified under international medical and safety standards to ensure full regulatory compliance and proven reliability.

classification

Product

Verified & documented classifications

This overview summarizes the official classification and regulatory framework for each device.

 

All classifications are independently verified through accredited laboratory testing and international certification standards.

Medical
device

Developed and classified under the European Medical Device Regulation (MDR, Annex VIII).

Electrical
devices

These devices are verified under international electrical and electromagnetic compatibility standards (IEC, CISPR) to ensure safe, contact-free operation and full regulatory compliance.

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